ID
33004
Descrição
Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the vital signs form. It has to be filled in at screnning, for session 2, 3,4, 5 and 6.
Palavras-chave
Versões (3)
- 14/11/2018 14/11/2018 -
- 22/11/2018 22/11/2018 -
- 23/11/2018 23/11/2018 - Sarah Riepenhausen
Titular dos direitos
GlaxoSmithKline
Transferido a
23 de novembro de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877
Vital signs
- StudyEvent: ODM
Descrição
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descrição
Row no.
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C0237753
Descrição
Date of vital signs
Tipo de dados
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0518766
Descrição
Time relative to dosing. Please fill out at least one measurement for screening and one pre-dose measurement for each treatment period. For all additional measurements choose "unscheduled".
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0439564
Descrição
00:00-23:59
Tipo de dados
time
Alias
- UMLS CUI [1]
- C0040223
Descrição
NOTE: HR and BP measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
Tipo de dados
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Descrição
NOTE: HR and BP measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
Tipo de dados
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Descrição
NOTE: HR and BP measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
Tipo de dados
integer
Unidades de medida
- beats / min
Alias
- UMLS CUI [1]
- C0018810
Descrição
Only for session 2-6.
Tipo de dados
integer
Unidades de medida
- °C
Alias
- UMLS CUI [1]
- C0005903
Similar models
Vital signs
- StudyEvent: ODM
C0518766 (UMLS CUI [1,2])
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